The Ministry of Health and Wellness (MoH&W) has urged HIV positive women of childbearing age who are willing to fall pregnant to use Dolutegravir, a drug also known as DTG, with caution and with advice from their clinicians.
In 2016, Botswana transitioned to the use of a new HIV treatment known as DTG that is used to treat HIV infection. DTG is one of the several antiretrovirals included in the ‘integrase inhibitor’ drug class.
DTG, when combined with two other medicines in a single fixed-dose combination pill, is globally considered to be amongst the best treatments for HIV currently available. However, its availability has been limited due to its high cost.
MoH&W deputy permanent secretary, Dr Morrison Sinvula said the ministry continues to monitor the use of DTG amongst those women.
He said the ministry recommended to HIV positive women, who are pregnant or desire to get pregnancy, to seek professional help if they either want to or are using the drug.
“HIV positive women who are currently on DTG and desiring pregnancy should visit their healthcare providers for appropriate advice.
Those who are pregnant and have conceived while on DTG should alert their healthcare providers so they can be counselled and advised appropriately.
For those women who are currently on DTG and do not desire pregnancy at this time, should consult their healthcare providers for effective contraception in addition to the use of condoms.
All women of childbearing age should be tested for pregnancy before initiating any DTG containing regiments,” he emphasised.
Furthermore, Sinvula pointed out that the potential safety issue was related to the development of spinal cord, the brain, the bone and surrounding tissues within the first 28 days of conception (at least one month) that is when the neural tube fails to completely form.
He further explained that there have been four cases of neural tube defects identified in 426 women who were taking DTG before they became pregnant from an ongoing study in Botswana.
He said neural tube defects may be related to foliate deficiency, other medications, obesity or genetic factors.
“Preliminary data suggests that the potential safety issues arise from a woman’s exposure to the drug only at the time of conception.
"There has been no infant born with a neural tube defect from women who started DTG after their first three
"To date, more than 2,500 women who began taking it after the time of conception have not reported any cases of neural tube defects,” he said.
Despite these preliminary findings, DTG has been proven to be a highly effective medication in Botswana and around the world.
Sinvula explained that the use of the DTG drug was introduced in the country because it is better tolerated, and leads to faster and sustained viral suppression.
He, however, stated that those findings were preliminary and the data was very limited at that time.
According to a September 2017WHO report, findings from HIV services in Botswana, which provided DTG to pregnant women with HIV for more than a year, demonstrate that birth outcomes (stillbirth, neonatal death, preterm birth and smallness for gestational age) do not differ between women receiving EFV-based therapy and those receiving DTG-based therapy.
“This observation is based on retrospectively collected data from more than 5,000 women, 16% of whom were receiving DTG regimens.
There was also no excess of congenital anomalies among infants born to women taking DTG, although relatively few of these women started DTG in the first trimester. Two different clinical trial networks have assessed DTG safety and pharmacokinetics in pregnant women, and reported that DTG was well-tolerated and reached levels expected to achieve HIV suppression.”
“Several clinical trials assessing the effectiveness, safety, tolerability and/or pharmacokinetics of DTG during pregnancy are either underway or about to start, with findings expected between 2018 and 2021,” it stated.
However, WHO reported that clinical trial development programmes frequently exclude children, pregnant women (PW) and people with HIV-associated tuberculosis (TB). It noted that to date, this lack of data has prevented WHO from being able to recommend these ARV drugs across all populations. The report stated the ongoing studies will provide data that can allow for a revision of this recommendation in the coming one to two years.
It further noted that, strengthened ARV post-marketing, ARV drug toxicity monitoring and pregnancy registry or congenital anomaly surveillance programmes are important sources of data to address these gaps.